Prescription drug · NDA
Ambelvist (gadoquatrane) NDC 50419-324
Gadoquatrane 257.9 mg/mL · Injection · Intravenous · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-324-11 | 50419032411 | 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-324-11) / 15 mL in 1 VIAL, SINGLE-DOSE (50419-324-01)Marketed from Jun 12, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ambelvist
- Generic name (nonproprietary)
- gadoquatrane
- Active ingredients
- Gadoquatrane — 257.9 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219627
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-324_7c4d8f12-64e0-465f-9b4b-99700e141febSPL ID 7c4d8f12-64e0-465f-9b4b-99700e141febSPL set ID fac80f5d-8d37-4237-bb52-0faef0dd46aaUNII OZG7J613HKUPC 0350419329118, 0350419327114
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450419032411followed by a unit qualifier and the quantityPackage 50419-0324-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) AMBELVIST is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 219627
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-321 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-322 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-323 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-327 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-326 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-330 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-328 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-329 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-331 |
| Ambelvistgadoquatrane | Gadoquatrane 257.9 mg/mL | InjectionIntravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-332 |